bupropion

Product NDC
71335-0785
11-digit product format
713350785
Labeler code
71335
Product ID
71335-0785_1d654c22-d2b9-429c-91cb-686249973287
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202304
Marketing category
ANDA
Marketing start
2014-11-01
Marketing end
0000-00-00
Substance
BUPROPION HYDROCHLORIDE
Active strength
150 mg/1
Pharmacologic classes
Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 10 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71335-0785DDiscontinued by firm2026-08-17
excluded packagepackage71335-078571335-0785-1DDiscontinued by firm2026-08-17
excluded packagepackage71335-078571335-0785-2DDiscontinued by firm2026-08-17
excluded packagepackage71335-078571335-0785-3DDiscontinued by firm2026-08-17
excluded packagepackage71335-078571335-0785-4DDiscontinued by firm2026-08-17
excluded packagepackage71335-078571335-0785-5DDiscontinued by firm2026-08-17
excluded packagepackage71335-078571335-0785-6DDiscontinued by firm2026-08-17
excluded packagepackage71335-078571335-0785-7DDiscontinued by firm2026-08-17
excluded packagepackage71335-078571335-0785-8DDiscontinued by firm2026-08-17
excluded packagepackage71335-078571335-0785-9DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 120 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0785-5d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0785-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0785-9d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0785-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0785-6d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0785-8d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0785-4d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0785-7d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0785-3d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0785-5f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0785-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0785-9f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0785-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0785-6f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0785-8f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0785-4f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0785-7f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0785-3f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0785-52ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0785-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0785-92ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0785-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0785-62ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0785-82ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0785-42ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0785-72ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0785-32ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0785-5a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0785-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0785-9a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0785-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0785-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0785-8a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0785-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0785-7a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0785-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0785-5cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0785-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0785-9cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0785-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0785-6cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0785-8cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0785-4cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0785-7cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0785-3cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0785-5cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0785-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0785-9cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0785-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0785-6cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0785-8cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0785-4cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0785-7cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0785-3cdf11ea48f46…ba0047e9e063…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202304-001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26
A202304-002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26
A202304-003BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A202304-001AB1
A202304-002AB1
A202304-003AB1

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A202304-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26caaa826d4ba7…
2026-08-18 06:07:402026-07A202304-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26caaa826d4ba7…
2026-08-18 06:07:402026-07A202304-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202304-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202304-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202304-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202304-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12015-05-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202304-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12015-05-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202304-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12015-05-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A202304-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12015-05-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202304-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12015-05-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202304-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12015-05-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202304-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202304-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202304-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202304-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202304-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202304-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202304-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12015-05-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202304-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12015-05-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202304-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12015-05-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202304-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12015-05-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202304-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12015-05-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202304-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12015-05-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202304-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12015-05-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202304-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12015-05-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202304-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12015-05-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202304-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202304-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202304-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202304-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A202304-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A202304-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202304-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12015-05-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202304-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12015-05-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202304-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12015-05-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202304-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202304-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202304-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202304-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12015-05-261e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A202304-001AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A202304-002AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A202304-003AB11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202304-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202304-002AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202304-003AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202304-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202304-002AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202304-003AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202304-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202304-002AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202304-003AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202304-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202304-002AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202304-003AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202304-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202304-002AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202304-003AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202304-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202304-002AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202304-003AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202304-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202304-002AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202304-003AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202304-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202304-002AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202304-003AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202304-001AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202304-002AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202304-003AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202304-001AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A202304-002AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A202304-003AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202304-001AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202304-002AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202304-003AB1179d66fd596c7…
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2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202304-003AB11301d65b070ca…
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DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0785-2EA - Each71335-0785e4e7ed26-0990-4db6-b532-cfe5aaad284312019-11-12
71335-0785-3EA - Each71335-0785e975f3b9-5e71-41cc-961a-43026f30f83312019-09-05

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
bupropion hydrochloride SRBUPROPION HYDROCHLORIDEMajor Pharmaceuticals67b6bcf8-0e7c-4e74-ad72-54f1bd6e65ad2026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202304
application number: ANDA202304
bupropion hydrochloride SRBUPROPION HYDROCHLORIDECardinal Health 107, LLC439a7e93-f578-434f-943f-4b93c35450f52026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202304
application number: ANDA202304
bupropion hydrochloride SRBUPROPION HYDROCHLORIDESolco Healthcare US LLC39b2d509-1281-4464-9cf1-a94bbc18b84b2026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202304
application number: ANDA202304
bupropion hydrochloride SRBUPROPION HYDROCHLORIDEREMEDYREPACK INC.850ac56a-ba50-4e61-b1ee-805e17735b5c2026-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202304
application number: ANDA202304
bupropionBUPROPION HYDROCHLORIDENorthwind Health Company, LLCab6cd2ea-507c-35e5-e053-2a95a90ac5cb2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202304
application number: ANDA202304
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEDIRECT RX96d87edc-d12b-44b2-e053-2995a90a4e632025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202304
application number: ANDA202304
bupropionBUPROPION HYDROCHLORIDEBryant Ranch Prepack7ded4fa6-e637-4d59-a1b1-286854d4fe3a2024-08-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202304
application number: ANDA202304
bupropionBUPROPION HYDROCHLORIDEProficient Rx LP909204fc-ff55-43d9-b9ee-e607ef60965e2022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202304
application number: ANDA202304

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0785-17133507850160 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0785-1) 2014-11-010000-00-00NoNoCurrent
71335-0785-27133507850290 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0785-2) 2018-05-170000-00-00NoNoCurrent
71335-0785-37133507850330 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0785-3) 2018-04-270000-00-00NoNoCurrent
71335-0785-471335078504120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0785-4) 2019-05-290000-00-00NoNoCurrent
71335-0785-57133507850545 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0785-5) 2022-01-280000-00-00NoNoCurrent
71335-0785-671335078506180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0785-6) 2018-10-010000-00-00NoNoCurrent
71335-0785-77133507850728 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0785-7) 2022-01-280000-00-00NoNoCurrent
71335-0785-87133507850856 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0785-8) 2022-05-020000-00-00NoNoCurrent
71335-0785-971335078509100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0785-9) 2022-05-020000-00-00NoNoCurrent